Impact of Insecticide Resistance on Vector Control

London School of Hygiene and Tropical Medicine

Status and phase: Unknown; Phase 4

Conditions: Malaria, Falciparum

Treatments: Other: Indoor residual insecticide spraying (IRS); Device: Long Lasting Insecticidal Nets (LLIN)

Study type: Interventional

Funder types: Other

Identifiers

NCT01713517

WHO_IR_SUDAN

Details and patient eligibility

About

The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

Full description

The study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. In each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. Resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.

Enrollment: 28,000 estimated patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas

Exclusion criteria

• Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28,000 participants in 2 patient groups

Universal coverage of Long Lasting Insecticidal Nets (LLIN)

Active Comparator group

Description:

Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons

Treatment:

Device: Long Lasting Insecticidal Nets (LLIN)

LLIN Plus Indoor Residual Spraying

Experimental group

Description:

Distribution of long lasting insecticidal nets to all community members in the study arm allowing for at least one net per 2 persons plus indoor residual spraying with insecticide of interior walls of all houses twice yearly.

Treatment:

Device: Long Lasting Insecticidal Nets (LLIN)

Other: Indoor residual insecticide spraying (IRS)